Status:
UNKNOWN
Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases
Lead Sponsor:
Institut Català d'Oncologia
Conditions:
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer to demonstrate...
Detailed Description
The intervention (dose and fractions) depends on topographical parameters: lung disease (primary, peripheral nodes or mediastinal nodes), distance to chest wall, tumour size and distance to main bronc...
Eligibility Criteria
Inclusion
- Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX\> 4).
- Tumour size \< 5 cm in diameter prior to treatment.
- Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.
- Life expectancy of \>12 months.
- Criterion for medical inoperability include:
- Overall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age \> 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \< 40% or less), resting or exercise arterial pO2 \< 55 mmHg, and pCO2 \> 45 mmHg.
- Age \> 18 years.
- KPS \> 70.
- Barthel score \>40
- Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.
- If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan.
- More than two lesions per lobe.
- Active infections requiring systemic antibiotics.
- Age \<18 years old.
- KPs \< 70.
- Barthel Total Score \< 40.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01823003
Start Date
June 1 2012
End Date
July 1 2020
Last Update
August 7 2019
Active Locations (1)
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1
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908